Singapore HSA registration DE0510434
Turner Smart-C X-Ray Imaging System
Singapore·CLASS C·Turner Imaging Systems,Inc·Registered March 07, 2025Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0510434
- Registration Date
- March 07, 2025
- Retention Due Date
- March 06, 2026
Product description
The Smart-C is a mini c-arm x-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.
Product Owner
- Short Name
- Turner Imaging Systems,Inc
- Address
- 1119 S 1680 W, Orem Utah 84058, UNITED STATES
Registrant
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model information
- Model Name(s)
- Footswitch Tablet Smart-C System Support Stand for Smart-C Monitor Cart for Smart-C
- Model Identifier(s)
- 838-00003-001 838-00018 962-00001-GB 962-00003-002-GB 962-00004-002-GB
About this record
Access comprehensive regulatory information for Turner Smart-C X-Ray Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510434 and owned by Turner Imaging Systems,Inc. The device was registered on March 07, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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